R&D Pipeline

Pipeline of Key Proprietary Product Candidates

Our R&D pipeline reflects Alkermes' commitment to advancing Great Science that has the potential to provide meaningful impact for patients. We have a pipeline of product candidates in development for psychiatric and neurological disorders.

The pipeline includes both investigational product candidates and investigational uses of approved products that have not been approved by a health authority. The information presented is not intended to convey conclusions of safety or efficacy. There is no guarantee that the outcome of these studies will result in approval by a health authority.

Discovery
Preclinical
Phase 1
Phase 2
Phase 3

Sodium oxybate extended-release oral suspension
- Idiopathic Hypersomnia
  
  Phase 3
A once-nightly formulation of sodium oxybate for extended-release oral suspension is currently being evaluated for use in adults with idiopathic hypersomnia in a phase 3 study, REVITALYZ. For more information about this study, please visit clinicaltrials.gov/study/NCT06525077.
Olanzapine and samidorphan
- Schizophrenia and Bipolar I Disorder (Pediatric)
  
  Phase 3
Olanzapine and samidorphan is currently being evaluated for pediatric use in a phase 3 study, ENLIGHTEN-Youth. For more information about this study, please visit enlightenyouthstudy.com (U.S. audiences only) or clinicaltrials.gov/study/NCT05303064.
Alixorexton
- Narcolepsy Type 1
  
  Phase 3
- Narcolepsy Type 2
  
  Phase 3
- Idiopathic Hypersomnia
  
  Phase 2
Alixorexton (formerly ALKS 2680) is an investigational, oral orexin 2 receptor agonist in development for the treatment of narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.

Alixorexton is currently being evaluted in the phase 3 Brilliance Studies program in adults with narcolepsy type 1 and narcolepsy type 2, and in Vibrance-3, a phase 2 study in adults with idiopathic hypersomnia. Participants who complete one of the Vibrance or Brilliance studies have the option to continue in a long-term, open-label, safety study evaluating the safety of alixorexton for up to two years.

For more information about enrolling studies, please visit brilliancestudies.com,
vibrancestudies.com (for U.S. audiences only), or clinicaltrials.gov for a list of current studies.
ALKS 4510
- Fatigue - Neurodegenerative Disorders*
  
  Phase 1
ALKS 4510 is an investigational orexin 2 receptor agonist in developement for the treatment of fatigue associated with multiple sclerosis and Parkinson's disease. It is currently being evaluated in a phase 1 study in healthy volunteers.
ALKS 7290
- Attention-Deficit Hyperactivity Disorder
  
  Phase 1
ALKS 7290 is an investigational orexin 2 receptor agonist in development for the treatment of attention-deficit hyperactivity disorder (ADHD). It is currently being evaluated in a phase 1 study in healthy volunteers.
Valiloxybate
- Narcolepsy and Idiopathic Hypersomnia
  
  Phase 1
Valiloxybate is an investigational GABA_B receptor agonist in development for the treatment of patients with narcolepsy and idiopathic hypersomnia. It is currently being evaluated in a phase 1 pharmacokinetic study in healthy volunteers.

*In patients with fatigue associated with multiple sclerosis and Parkinson's disease
Last updated: April 2026